MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-53

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Ischemia (1942)

Event Date 07/02/2021

Event Type  Injury  

Event Description

As reported via medwatch # (b)(4).Received 28-september-2021: patient was in cath lab undergoing diagnostic cardiac catheterization.The cs300 intra-aortic balloon pump (iabp) balloon was inserted in the right femoral artery for possible urgent cabg (coronary artery bypass graft).The balloon pump became dislodged in the femoral artery.Patient was taken to or.The leg appeared ischemic.Surgeon decided to remove iabp by cutting down the right groin and remove the iabp under direct vision.The cfa (common femoral artery) was repaired with 6-0 prolene stitches.Surgeon proceeded with planned cabg.Surgeon stated that situation was emergent but resulted in no permanent harm.The biomed has reported they are unable to verify which of the three balloon pumps was involved.The intra-aortic balloon catheter is being submitted on a separate report.

Manufacturer Narrative

At this time, the customer has not requested for getinge to evaluate the iabp unit involved in this event.Attempts are being made to the customer to seek additional information.If additional information is provided, a supplemental report will be submitted.Note: the serial number reported herein is the serial number reported on the medwatch although it also reported that the biomed was not able to identify which pump was used.The related intra-aortic balloon (iab) has been reported under medwatch report number 2248146-2021-00685.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12683061
• MDR Text Key: 281288560
• Report Number: 2249723-2021-02439
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/05/2008
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: IAB, CARDIAC DRUGS, OTHER, SEDATIVES, ANXIOLITICS
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Female